Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000861358
Ethics application status
Approved
Date submitted
6/06/2017
Date registered
13/06/2017
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Date results provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we use a test of spatial relationships to identify future doctors who might benefit from increased training to better perform ultrasound-guided regional anaesthesia?
Scientific title
Does Targeted Educational Intervention based on Psychometric Screening Improve Ultrasound-Guided Regional Anaesthesia Performance in medical students?
Secondary ID [1] 292136 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medical students with low spatial relationships as screened using the Mental Rotations Test-A 303560 0
Condition category
Condition code
Public Health 302970 302970 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this prospective, multicentre, 1:1 allocation, double blinded, stratified randomised interventional (non-drug) trial, we will perform screening of innate spatial relationships on medical students ("participants") recruited into the study. This is performed using the revised Mental Rotations Test-A (MRTA). This paper and pen based form is validated and standardised for visuopatial skills testing. The test is timed, has explicit instructions to be read out verbatim to participants, and the entire test takes 15 minutes.

Using population norms, participants are stratified into low (below mean) and high (above mean) ability groups. Participants are then randomised into control (discovery learning) or intervention (deliberate practice) training, creating 4 groups: low-control, low-intervention, high-control, and high-intervention.

Each participant will then be brought individually to an identical in vitro benchtop pork model and be asked to perform an ultrasound-guided regional anaesthesia (UGRA) needle task. The attempt will be recorded as time taken (seconds), and evaluated using a global rating scale previously used for UGRA assessment. This is the baseline test.
Physician anaesthetists who are experts in UGRA will conduct these assessments. This will be assessed in real-time, while the participant performs the task. These “examiners” are blinded to participant MRTA scores and group allocation. The examiners are not involved in any other training of participants.

After performance of baseline testing, the intervention group receives deliberate practice in UGRA skills. Deliberate practice is a technique of 1 on 1 teaching by expert faculty using graded goals and providing feedback after every attempt. This training period lasts 20 minutes. Faculty are also physician anaesthetists, not involved in assessment. The control group receives discovery learning, an educational technique where participants explore how to perform the UGRA task by themselves. They will also have 20 minutes of discovery training.

After training, all participants are brought back to the benchtop model and asked to repeat the UGRA task. They will be timed and their procedural skill assessed using the global rating scale by the examiner anaesthetists. This is the final test.
Intervention code [1] 298279 0
Treatment: Other
Comparator / control treatment
The control group receives discovery learning. This group is allowed the same time (20min), access to identical models and equipment as the intervention group. However, no expert faculty is involved with discovery learning.
Control group
Active

Outcomes
Primary outcome [1] 302357 0
Time taken to complete the UGRA task, recorded on a stopwatch by a research assistant from picking up the needle and injecting saline into the 6- and 12-o'clock positions of the in vitro nerve benchtop model
Timepoint [1] 302357 0
immediately after MRTA screening (baseline test), and after exposure to educational control or intervention (final)
Secondary outcome [1] 335713 0
proficiency score on a global rating scale
Timepoint [1] 335713 0
at baseline, and at final tests

Eligibility
Key inclusion criteria
medical students
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with any previous training, tutorials, workshops or actual performance of UGRA.
Participants with prior psychometric or neurocognitive testing in the past 12 months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant allocation is concealed by using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified randomisation. Stratification by visuospatial ability. Then randomisation by computerised allocation into groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Determining the effect of targeted deliberate practice will be assessed using repeated measures mixed ANOVA of the primary endpoint of time taken to complete the UGRA task from baseline to final testing. Thus, the comparisons will be between the low-intervention and high-intervention groups, and between the low-intervention and high-control groups.

The effect of targeted deliberate practice on the secondary endpoint of global rating scores between the low-intervention and high-intervention groups, and between the low-intervention and high-control groups, will use repeated measures ANOVA.

To measure the effect of deliberate practice as an educational intervention versus no training, comparisons will be made between the low-intervention and low-control groups, and between the high-intervention and high-control groups. These analyses will use repeated measures mixed ANOVA for time taken, and for global rating scale scores.
All analyses will use Bonferroni corrected, two-tailed p values < 0.05 for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
1/01/2018
Date of last participant enrolment
Anticipated
Actual
26/05/2019
Date of last data collection
Anticipated
Actual
26/05/2019
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8305 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 16368 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 8954 0
Canada
State/province [1] 8954 0
Ontario
Country [2] 8955 0
Ireland
State/province [2] 8955 0
Cork

Funding & Sponsors
Funding source category [1] 296673 0
Hospital
Name [1] 296673 0
Liverpool Hospital Department of Anaesthesia
Country [1] 296673 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 295633 0
None
Name [1] 295633 0
Address [1] 295633 0
Country [1] 295633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297900 0
South Western Sydney HREC
Ethics committee address [1] 297900 0
Ethics committee country [1] 297900 0
Australia
Date submitted for ethics approval [1] 297900 0
19/06/2017
Approval date [1] 297900 0
01/08/2018
Ethics approval number [1] 297900 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75406 0
Dr Alwin Chuan
Address 75406 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 75406 0
Australia
Phone 75406 0
+61407743668
Fax 75406 0
Email 75406 0
[email protected]
Contact person for public queries
Name 75407 0
Alwin Chuan
Address 75407 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 75407 0
Australia
Phone 75407 0
+61407743668
Fax 75407 0
Email 75407 0
[email protected]
Contact person for scientific queries
Name 75408 0
Alwin Chuan
Address 75408 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 75408 0
Australia
Phone 75408 0
+61407743668
Fax 75408 0
Email 75408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12469Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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